TECHNOLOGIES TO FIND FUNCTIONAL ELEMENTS IN GENOMIC DNA
RELEASE DATE: January 6, 2004
RFA Number: RFA-HG-04-001
August 4, 2006 - This RFA has been reissued as RFA-HG-07-029 (R01)
and RFA-HG-07-028 (R21).
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov/)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Human Genome Research Institute (NHGRI)
(http://www.genome.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S) 93.172
LETTER OF INTENT RECEIPT DATE: February 20, 2004
APPLICATION RECEIPT DATE: March 23, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The purpose of this RFA is to solicit applications to develop new
technologies for the efficient, comprehensive, high-throughput
identification and verification of all types of sequence-based
functional elements, particularly those other than coding sequences for
which adequate methods do not currently exist. This effort is part of
the Encyclopedia of DNA Elements (ENCODE) Project, the intent of which
is to identify all functional elements in the human genome sequence
(http://www.genome.gov/10005107). This RFA will augment the ongoing
work of the ENCODE Consortium, which is (a) conducting a pilot project
to test the ability of current methodologies to identify exhaustively
the functional elements in a targeted region of the human genome and (b)
supporting the development of new technology. Although all aspects of
technology development will be considered, the emphasis for this RFA is
on the development of completely novel techniques for identifying
sequence-based functional elements in the genomes of eukaryotic
organisms, especially heretofore uncharacterized elements, rather than
on the incremental improvement of existing methods.
RESEARCH OBJECTIVES
Background
In April 2003, the sequence of the human genome was essentially
completed. For the scientific community to make the best use of that
fundamental information resource, the identity and precise location of
all sequence-based functional elements in the genome must be determined.
While many of the protein-coding sequences are already known, many
others remain to be identified. Beyond open reading frames, most other
sequence-based functional elements, such as non-protein-coding genes,
transcriptional regulatory elements and determinants of chromosome
structure and function, remain largely unknown. A comprehensive
encyclopedia of all of these features is needed to fully utilize the
sequence of the human genome to better understand human biology, to
predict potential disease risks, and to stimulate the development of new
therapies and other interventions for preventing and treating disease.
Among the primary reasons for the success of the Human Genome Project
have been the development and use of high-throughput strategies for data
generation, and the placement of the data immediately in the public
domain. Most of the sequence data, the underlying maps and the sequence
assemblies were generated through the use of large-scale automated
processes. Now, methods such as sequence analysis of whole genomes, DNA
microarray technology and mass spectrometry have been or are being
developed as high-throughput approaches for additional types of genomic
analyses, such as determining the parameters of gene expression and of
the location of gene products by the thousands at a time instead of
individually. High-throughput methods to determine the location of cis-
regulatory elements and, to a lesser extent, other sequence elements,
are also beginning to be developed. However, at present, there is no
single approach or compilation of approaches that can accurately and
efficiently identify every sequence feature in genomic DNA.
To address this need, the NHGRI recently initiated the Encyclopedia of
DNA Elements (ENCODE) Project, the goal of which is to comprehensively
identify sequence-based functional elements in the human genome
sequence. The ENCODE Project currently has two components. The first
is a pilot in which existing methods for the exhaustive identification
and verification of functional sequence elements are being tested and
compared in a fraction (30 Mb) of human genomic DNA. This pilot is
focused on established technologies that can primarily be applied to
identify coding sequences, transcriptional units, and transcriptional
control elements. The second component of the ENCODE Project addresses
the need for new technologies that will be necessary to identify all
sequence-encoded functional elements on a genome-wide scale. To this
end, an initial set of grants was funded, under RFA HG-03-004, to
develop novel technologies designed to effect systematic and high-
throughput approaches to the comprehensive identification of functional
sequence elements in the human genome. The current RFA (HG-04-001) is a
reissuance of that RFA with an expansion in scope to include the support
for high risk projects, for testing new ideas for which preliminary data
have not yet been obtained, and for the development of new approaches to
identify sequence-based functional elements in the genomes of model
organisms even if such methods are not directly applicable to
identifying features in the human genome. The goal of RFA HG-04-001 is
to develop a new generation of methods to define functional elements in
genomes of both human and model organisms.
Research Scope
When fully mature, the ENCODE Project will apply a set of high-
throughput assays to scan the entire human genome for all types of
sequence-encoded functional elements. However, many types of functional
elements cannot currently be studied at such large scale, or even at
smaller scale, because of the lack of effective, practical high-
throughput methods. The purpose of this RFA is to stimulate the
development of novel technologies and expand the “tool box” for
identifying all sequence-based functional elements in eukaryotic genomes
in a high-throughput manner. The RFA seeks applications for research
projects to develop efficient technologies (both experimental and
computational) for, but not limited to, the following areas:
o Transcribed sequences; while the emphasis is on non-protein coding
transcribed sequences, new approaches to identifying protein-coding
transcribed sequences will be considered. A description of the entire
structure of the transcriptional unit, with transcriptional start sites,
polyadenylation sites, and all alternative transcripts, is an example.
o Conserved non-coding sequences that represent functional elements.
o Cis-acting elements that regulate gene expression at either the
transcriptional or post-transcriptional levels, for example promoters,
enhancers, insulators, and features that regulate RNA stability and
translation.
o Sequence features that affect or control various aspects of
chromosome biology, including chromatin structure. Examples include
origins of replication and hot spots for recombination.
o Epigenetic changes, such as DNA methylation and chromatin
modifications.
These few examples are illustrative and should not be considered to be
limiting in any way. Novel and innovative technologies to achieve high-
throughput, large-scale analyses (i.e., applicable to an entire genome)
of any type of sequence-encoded functional elements are sought.
The "process" of technology development can be considered to span a
spectrum of stages. Initially, it involves the development of an
entirely new methodology (or the significant improvement of an existing
methodology) to the point of proof of principle. The method must then be
reduced to practice. For such a new method to have a significant impact
for genomic studies, it also must be shown that it can be used
efficiently on a large-scale, or genomic basis, which may require a
further round of technology development effort. This RFA is intended to
solicit applications that address any of these phases of technology
development, with an emphasis on the development of completely novel
techniques for identifying sequence-based functional elements,
especially heretofore uncharacterized elements, rather than on the
incremental improvement of existing methods.
Although the long term goal of the ENCODE project is to develop a
comprehensive understanding of the human genome sequence, this RFA is
open to projects employing any other eukaryotic organism. Technology
development in other organisms can aid in the identification of
functional elements in the human genome in two ways: the technologies
may be applicable to the human genome, or although uniquely applicable
to specific genomes because of the characteristics of the organism,
provide biological insights into functional elements that could not be
determined from experiments in the human. The application of the
proposed technology to organisms other than the one that is the focus of
the application is not a requirement of this RFA. However, applicants
should address the issue of broader application of the technology, if
appropriate.
An important feature of any newly developed technology will be the ease
with which it can be exported into other laboratories, or in other ways
made readily accessible to investigators. The issue of access, or
technology transfer, should be specifically discussed in the grant
application.
The development of computational methods for the study of genomic
function is encouraged under this solicitation. However, computational
methods that incrementally improve on current technologies are not being
sought. Any software developed under this RFA should be freely available
to other biomedical researchers in the non-profit sector.
As the technologies to be developed under this RFA are expected to be
applied eventually to an entire genome, applications proposing to
analyze a particular gene, gene product or non-coding functional element
will not be considered to be responsive.
To encourage the consideration of novel approaches, applicants
responding to this RFA are not required to have preliminary data.
However, the research project must be well designed, must be
scientifically and technically sound, and should propose alternative
solutions. In the absence of preliminary data, applicants are encouraged
to present any other information that can be considered as evidence of
feasibility.
As the work funded under this RFA progresses, the principal
investigators will be encouraged to interact with the ENCODE pilot
project consortium and its members. If work supported under this RFA,
such as a computational analysis, results in the generation of data
pertaining to the complete set of target regions of the ENCODE project,
the principal investigator may be invited to join the consortium (see
http://www.genome.gov/10005107 for a description of the consortium).
Among other requirements, this would involve sharing of the data with
the members of the consortium, as participation involves concurrence
with a specific data release policy (see RFA HG-03-003 for a detailed
description of that policy). Applicants to HG-04-001 may wish to
address their approach to data release in their proposal.
MECHANISM OF SUPPORT
This RFA will use the NIH investigator-initiated Research Project Grant
(R01) and the Exploratory/Development Research Grant (R21) award
mechanisms. As an applicant you will be solely responsible for
planning, directing, and executing the proposed project. The total
requested project period for an application submitted in response to
this RFA may not exceed 3 years for the R01 mechanism, and 2 years for
the R21 mechanism. The anticipated award date is September 30, 2004.
This RFA is a one-time solicitation. Applications that are not funded
in the competition described in this RFA may be resubmitted as NEW
investigator-initiated applications using the standard receipt dates for
NEW applications described in the instructions to the PHS 398
application (see
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-019.html).
The R21 mechanism (Exploratory/Developmental grant) is intended to
encourage new exploratory/ developmental research projects by providing
support for the early stages of their development. Awards are made to
demonstrate feasibility of a subsequent project and to obtain
preliminary data testing innovative ideas. Therefore, these grants are
not renewable. Continuation of projects developed under this program
will be through the regular research project grant mechanism (for
example, R01).
This RFA uses just-in-time concepts. It also uses the modular as well
as the non-modular budgeting formats (see
https://grants.nih.gov/grants/funding/modular/modular.htm).
Specifically, if you are submitting an application with direct costs in
each year of $250,000 or less, use the modular budget format. Otherwise
follow the instructions for non-modular budget research grant
applications. This program does not require cost sharing as defined in
the current NIH Grants Policy Statement at
https://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.
FUNDS AVAILABLE
The NHGRI intends to commit approximately $2 million in FY2004 to fund
6 to 10 new and/or competitive continuation grant applications in
response to this RFA. An applicant may request a project period of up
to 3 years and a budget of up to $350,000 direct costs per year for an
R01 application. For an R21 application, a project period of up to 2
years and a budget for direct costs of up to $100,000 for up to two
years may be requested. Because the nature and scope of the proposed
research will vary from application to application, it is anticipated
that the size and duration of each award may vary. Awards pursuant of
this RFA are contingent upon the availability of funds and the receipt
of a sufficient number of meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign institutions/organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to
carry out the proposed research is invited to work with their
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH programs.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into
three areas: scientific/research, peer review, and financial or grants
management issues:
o Direct your questions about scientific/research issues to:
Elise Feingold, PhD or Peter Good, PhD
Program Directors
Division of Extramural Research
NHGRI
Building 31, Room B2B07
31 Center Drive, MSC 2033
Bethesda, MD 20892-2033
Telephone: (301) 496-7531
FAX: (301) 480-2770
Email: Elise_Feingold@nih.gov or Peter_Good@nih.gov
o Direct your questions about peer review issues to:
Rudy Pozzatti, PhD
Scientific Review Administrator
Review Branch
Division of Extramural Research
NHGRI
Building 31, Room B2B37
31 Center Drive, MSC 2032
Bethesda, MD 20892-2032
Telephone: (301) 402-8739
FAX: (301) 435-1580
Email: pozzattr@exchange.nih.gov
o Direct your questions about financial or grants management matters to:
Jean Cahill
Chief, Grants Administration Branch
Division of Extramural Research
NHGRI
Building 31, Room B2B34
31 Center Drive, MSC 2031
Bethesda, MD 20892-2031
Telephone: (301) 301-435-7858
FAX: (301) 402-1951
Email: cahillj@mail.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning
of this document. The letter of intent should be sent to:
Peter Good, PhD
Program Director
Division of Extramural Research
NHGRI
Building 31, Room B2B07
31 Center Drive, MSC 2033
Bethesda, MD 20892-2033
Telephone: (301) 496-7531
FAX: (301) 480-2770
Email: Peter_Good@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). Applications must
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS)
number as the Universal Identifier when applying for Federal grants or
cooperative agreements. The DUNS number can be obtained by calling
(866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on
line 11 of the face page of the PHS 398 form. The PHS 398 is available
at https://grants.nih.gov/grants/funding/phs398/phs398.html in an
interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in
a modular grant format. The modular grant format simplifies the
preparation of the budget in these applications by limiting the level of
budgetary detail. Applicants request direct costs in $25,000 modules.
Section C of the research grant application instructions for the PHS 398
(rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html
includes step-by-step guidance for preparing modular grants. Additional
information on modular grants is available at
https://grants.nih.gov/grants/funding/modular/modular.htm.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at:
https://grants.nih.gov/grants/funding/phs398/labels.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original
of the application, including the Checklist, and three signed,
photocopies, in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application must
be sent to:
Rudy Pozzatti, PhD
Scientific Review Administrator
Review Branch
Division of Extramural Research
NHGRI
Building 31, Room B2B37
31 Center Drive, MSC 2033
Bethesda, MD 20892-2033
Telephone: (301) 402-8739
FAX: (301) 435-1580
Email: pozzattr@exchange.nih.gov
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the
applicant without review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and
funding assignment within 8 weeks.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to an RFA, it is to be prepared as a NEW
application. That is, the application for the RFA must not include an
Introduction describing the changes and improvements made, and the text
must not be marked to indicate the changes from the previous unfunded
version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the NHGRI.
Incomplete applications will not be reviewed.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NHGRI in accordance with the review
criteria stated below. As part of the initial merit review, all
applications will:
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications
under review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the NHGRI National Advisory Council
for Human Genome Research.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments, reviewers will be asked to evaluate the
application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. The
scientific review group will address and consider each of the following
criteria in assigning the application’s overall score, weighting them
as appropriate for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be
judged likely to have major scientific impact and thus deserve a high
priority score. For example, an investigator may propose to carry out
important work that by its nature is not innovative but is essential to
move a field forward.
SIGNIFICANCE: Does the application address the problem outlined in this
RFA? If the aims of the application are achieved, how will scientific
knowledge be advanced? What will be the effect of these studies on the
concepts or methods that drive this field?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of
the project as outlined in this RFA? Are potential problem areas
acknowledged and alternative tactics considered? Does the technical
approach have the potential to be applied efficiently and cost-
effectively at large scale?
INNOVATION: Does the project employ novel concepts, approaches, or
methods for identifying and verifying sequence-based functional
elements? Does the project challenge existing paradigms or develop new
methodologies or technologies rather than providing an incremental
improvement over existing technologies? Does the project develop new
methods or technologies to reduce costs or increase quality or
throughput?
INVESTIGATOR: Is the principal investigator appropriately trained and
well suited to carry out this work? Is the work proposed appropriate to
the experience level of the principal investigator and other
researchers (if any)?
ENVIRONMENT: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and the priority score:
TECHNOLOGY DISSEMINATION: Does the applicant provide a plan for making
the technology available to other labs? Will any software produced be
freely available to biomedical researchers in the non-profit sector?
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of
human subjects and protections from research risk relating to their
participation in the proposed research will be assessed. (See criteria
included in the section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy
of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific
goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the
sections on Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals
are to be used in the project, the five items described under Section f
of the PHS 398 research grant application instructions (rev. 5/2001)
will be assessed.
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: February 27, 2004
Application Receipt Date: March 26, 2004
Peer Review Date: June-July 2004
Council Review: September 2004
Earliest Anticipated Start Date: September 30, 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities, including the likelihood that the proposed
technology could be applied to the ENCODE project in a timely manner and
the range of technologies that could be developed under this component
of the ENCODE project. Preference will be given to applications that
propose the development of completely novel technologies and/or the
study of novel sequence elements.
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated
with reference to the risks to the subjects, the adequacy of protection
against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to
be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required
for all types of clinical trials, including physiologic, toxicity, and
dose-finding studies (phase I); efficacy studies (phase II); efficacy,
effectiveness and comparative trials (phase III). The establishment of
data and safety monitoring boards (DSMBs) is required for multi-site
clinical trials involving interventions that entail potential risk to
the participants. NIH Policy for Data and Safety Monitoring, NIH Guide
for Grants and Contracts, June 12, 1998:
https://grants.nih.gov/grants/guide/notice-files/not98-084.html.
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking $500,000 or more in
direct costs in any single year are expected to include a plan for data
sharing or state why this is not possible.
https://grants.nih.gov/grants/policy/data_sharing. Investigators should
seek guidance from their institutions, on issues related to
institutional policies, local IRB rules, as well as local, state and
Federal laws and regulations, including the Privacy Rule. Reviewers
will consider the data-sharing plan but will not factor the plan into
the determination of the scientific merit or the priority score.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy
of the NIH that women and members of minority groups and their sub-
populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health of
the subjects or the purpose of the research. This policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new
OMB standards; clarification of language governing NIH-defined Phase III
clinical trials consistent with the new PHS Form 398; and updated roles
and responsibilities of NIH staff and the extramural community. The
policy continues to require for all NIH-defined Phase III clinical trials
that: a) all applications or proposals and/or protocols must provide a
description of plans to conduct analyses, as appropriate, to address
differences by sex/gender and/or racial/ethnic groups, including
subgroups if applicable; and b) investigators must report annual accrual
and progress in conducting analyses, as appropriate, by sex/gender and/or
racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the NIH, unless there are scientific and
ethical reasons not to include them. This policy applies to all initial
(Type 1) applications submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects that is available at
https://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for
research involving human subjects. You will find this policy
announcement in the NIH Guide for Grants and Contracts Announcement,
dated June 5, 2000, at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at http://stemcells.nih.gov/index.asp and
at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human
Embryonic Stem Cell Registry will be eligible for Federal funding (see
http://escr.nih.gov). It is the responsibility of the applicant to
provide, in the project description and elsewhere in the application as
appropriate, the official NIH identifier(s) for the hESC line(s)to be
used in the proposed research. Applications that do not provide this
information will be returned without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access to research data through the Freedom of
Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency
in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has
provided guidance at
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design
and include information about this in the budget justification section
of the application. In addition, applicants should think about how to
structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under
this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:
The Department of Health and Human Services (DHHS) issued final
modification to the “Standards for Privacy of Individually Identifiable
Health Information”, the “Privacy Rule,” on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the
protection of individually identifiable health information, and is
administered and enforced by the DHHS Office for Civil Rights (OCR).
Those who must comply with the Privacy Rule (classified under the Rule
as “covered entities”) must do so by April 14, 2003 (with the exception
of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule
reside with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule,
including a complete Regulation Text and a set of decision tools on “Am
I a covered entity?” Information on the impact of the HIPAA Privacy
Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts
can be found at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation, Internet
addresses (URLs) should not be used to provide information necessary to
the review because reviewers are under no obligation to view the
Internet sites. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This RFA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.healthypeople.gov/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov and is not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act
as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52
and 45 CFR Parts 74 and 92. All awards are subject to the terms and
conditions, cost principles, and other considerations described in the
NIH Grants Policy Statement. The NIH Grants Policy Statement can be
found at https://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care,
health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.